Bio-Scriptives Extreme AF

Product NDC: 60608-013
11-digit product format: 606080013
Labeler code: 60608
Product ID: 60608-013_21203d45-e7b4-4bb2-a475-f8711a6ba65d
Type: HUMAN OTC DRUG
Nonproprietary name: Tolnaftate
Dosage form: CREAM
Route: TOPICAL
Labeler: BioChemics, Inc.
Application: part333C
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-07-27
Marketing end: 0000-00-00
Substance: TOLNAFTATE
Active strength: 1 g/56.69g
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60608-013		I	Inactivated by FDA	2026-10-05
excluded product	product	60608-013		D	Discontinued by firm	2026-10-05
excluded product	product	60608-013		D	Discontinued by firm	2026-10-05
excluded package	package	60608-013	60608-013-00	I	Inactivated by FDA	2026-10-05
excluded package	package	60608-013	60608-013-00	D	Discontinued by firm	2026-10-05
excluded package	package	60608-013	60608-013-00	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 92 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60608-013-00	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60608-013-00	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60608-013-00	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60608-013-00	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60608-013-00	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60608-013-00	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60608-013-00	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60608-013-00	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60608-013-00	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60608-013-00	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60608-013-00	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60608-013-00	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60608-013-00	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60608-013-00	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60608-013-00	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60608-013-00	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60608-013-00	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60608-013-00	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60608-013-00	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60608-013-00	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60608-013-00	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60608-013-00	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60608-013-00	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60608-013-00	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60608-013-00	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60608-013-00	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60608-013-00	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60608-013-00	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60608-013-00	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60608-013-00	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60608-013-00	2019-10-29	C162847	48780-1	960f7f55-d5d7-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60608-013-00	Bio-Scriptives Extreme AF	56.69 g in 1 BOTTLE, PUMP	CREAM	56.69		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
ALTHAEA OFFICINALIS ROOT	INACTIVE INGREDIENT	TRW2FUF47H	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
ARGININE HYDROCHLORIDE	INACTIVE INGREDIENT	F7LTH1E20Y	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
ASCOPHYLLUM NODOSUM	INACTIVE INGREDIENT	168S4EO8YJ	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
AZADIRACHTA INDICA SEED OIL	INACTIVE INGREDIENT	4DKJ9B3K2T	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
ECHINACEA ANGUSTIFOLIA LEAF	INACTIVE INGREDIENT	FS7G8S6PJ8	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
EUCALYPTUS GLOBULUS LEAF	INACTIVE INGREDIENT	S546YLW6E6	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
MELALEUCA ALTERNIFOLIA LEAF	INACTIVE INGREDIENT	G43C57162K	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
TAGETES ERECTA FLOWER	INACTIVE INGREDIENT	UH5X33P33E	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60608-013	BIO-SCRIPTIVES EXTREME AF (TOLNAFTATE) CREAM [BIOCHEMICS, INC.]	6	Legacy NDC, 1 package rows	20110727_e901c834-dcac-4d12-85f2-655ca9239cfe.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
06KB629TKV	TOLNAFTATE	2398-96-1	TOLNAFTATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
103951	tolnaftate 1 % Topical Cream	PSN	e901c834-dcac-4d12-85f2-655ca9239cfe	6
103951	tolnaftate 10 MG/ML Topical Cream	SCD	e901c834-dcac-4d12-85f2-655ca9239cfe	6
103951	tolnaftate 1 % Topical Cream	SY	e901c834-dcac-4d12-85f2-655ca9239cfe	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
60608-013-00	60608001300	56.69 g in 1 BOTTLE, PUMP	56.69 g	Historical